SMALL CLINICAL GRANTS IN DIGESTIVE DISEASES, NUTRITION AND OBESITY
RELEASE DATE: April 1, 2004
PA NUMBER: PAR-04-082
March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date. The
non-AIDS portion of this funding opportunity expires on the date indicated below.
Replacement R21 funding opportunities (PA-06-301 and PA-06-256) have been issued
for the submission date of June 1, 2006 and submission dates for AIDS and
non-AIDS applications thereafter.
EXPIRATION DATE for Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for AIDS and AIDS-Related Applications: May 2, 2006
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S): 93.848
This Program Announcement (PAR) replaces PAR-01-056, which was published in
the NIH Guide on February 22, 2001.
THIS PAR CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PAR
This PAR supersedes PAR-01-056 published in 2001. The goal of this
initiative is to encourage innovative clinical and epidemiological research
into new therapies or means of prevention of digestive and liver diseases,
nutritional disorders and obesity. The Small Clinical Research Grants
Program is designed to support short-term clinical studies and help stimulate
the translation of promising and potentially relevant new developments from
the laboratory into the clinical setting. This PAR specifically encourages
the submission of applications for pilot studies relating to
gastrointestinal, pancreatic and liver diseases and nutritional disorders
including obesity. They should focus on research that is particularly
innovative and/or potentially of high impact. High impact research involves
feasibility studies in which the technological, methodological, or
theoretical approach to a problem lacks an historical precedent or sufficient
preliminary data, but whose successful outcome would have a major effect on a
scientific area.
The small grants may be used as planning grants for full-scale multi-center
clinical trials or for pilot studies that could lead to full-scale multi-
center clinical trials designed to provide evidence for or against changes in
the current standard of care. Such trials may use pharmacological, dietary,
surgical, endoscopic, physical activity, or behavioral interventions aimed at
disease therapy or prevention. Pilot epidemiological studies are encouraged
that could lead to more extended research that would provide evidence for or
against changes in health policy, especially as related to disease
prevention. It is expected that these small clinical grants will serve as a
basis for planning future multi-center research project grant applications
(R01) or cooperative agreement (U01) awards.
The major changes in this PAR are a refocus on different priority areas and
an added stress placed upon innovative approaches to translate new findings
from basic research into practical means of diagnosis, treatment and
prevention of digestive and nutritional diseases (bench-to-bedside research).
RESEARCH OBJECTIVES
Background
The goal of this small grants program is to provide flexibility for
initiating preliminary, short-term studies, thus allowing new ideas to be
investigated in a more expeditious manner without stringent requirements for
preliminary data. Such support is needed to encourage experienced
investigators as well as new investigators to pursue new approaches,
underdeveloped topics, or more creative avenues of research. If successful,
these awards should lead to significant scientific advances in digestive
disease and nutrition research and should facilitate translation into
clinical practice.
One focus of this PAR is on diseases that ordinarily have little research
support because they are uncommon or rare, or difficult to manage, or are not
the focus of pharmacological therapy. There are several rare digestive
diseases that may, nevertheless, have lasting and major consequences for the
patients who have these conditions. These conditions are particularly
challenging when they occur in children and have life-long consequences.
These diseases are often too rare to be adequately investigated by a single
individual or at a single medical research institution. For these reasons,
applications for study of these conditions might be best performed by a
consortium of investigators that come together with a common protocol to
focus on natural history and clinical investigation rather than a specific
therapeutic intervention. Examples of these rare or uncommon digestive and
liver diseases that are of particular focus in this PAR include
gastrointestinal motility disorders of children; eosinophilic
gastroenteritis, intestinal pseudoobstruction, Wilson’s disease; sclerosing
cholangitis in children; hepatic congenital fibrosis; autoimmune hepatitis;
primary biliary cirrhosis; and familial pancreatitis.
Many digestive diseases and nutritional disorders are diagnosed, monitored or
treated using endoscopic or surgical techniques. These techniques are often
the consequence of years of study and development by a talented and
innovative investigator or group of investigators. Once the final technique
is developed and reported in the medical literature, however, there is often
little independent analysis of its efficacy and risk-benefit ratio. Thus,
endoscopic management of gastrointestinal bleeding, gastroesophageal reflux
disease, Barrett’s esophagus, retained biliary stones, pancreatitis and
colonic ectasia may be widely practiced but have not been subjected to
careful, large-scale, prospective randomized controlled trials. Among
surgical procedures in digestive and nutritional disorders, there is also
often little controlled evidence for efficacy and safety. Thus, small bowel
transplantation, the use of living donor liver transplantation, the surgical
therapy of obesity are a few areas in which surgical techniques have been
introduced and widely used without controlled observations on the efficacy
and relative safety of these approaches. This PAR is meant to provide a
means for investigators to develop prospective randomized controlled trials
of endoscopic and surgical therapies.
Additional areas of special focus of this PAR are hepatitis B and C. These
two diseases are major causes of morbidity and mortality from liver disease
in the United States. Current estimates suggest that chronic hepatitis B
affects 1 million and hepatitis C approximately 3 million Americans.
Hepatitis C accounts for at least 30% of liver transplants done in the United
States, while hepatitis B and its complications account for 5-10% of
transplants. While there are many industry sponsored studies of new and
innovative therapies of these diseases, many important approaches to the
management, prevention and treatment of acute and chronic hepatitis B and C
are outside of the usual interest of industry-sponsors of clinical trials.
Thus, use of cytokines, innovative combination therapies, iron depletion, and
complementary and alternative medical (CAM) treatments of hepatitis B and C
might be the focus of a small grant application. In addition, approaches to
management and therapy of hepatitis B and C in special populations might be
the focus of a small grant application; such populations might include
children, patients with hemophilia, patients with renal failure, solid-organ
transplant patients, patients with human immunodeficiency virus co-infection,
injection drug users, patients with continuing problems with alcohol or
substance abuse, and patients with significant psychiatric disease, such as
schizophrenia and bipolar disorders.
Acute hepatitis C currently accounts for 20% of cases of acute viral
hepatitis. Importantly, between 50 and 80% of persons with acute hepatitis C
develop chronic infection and thus are at risk of the long-term consequences
of this disease, such as cirrhosis, hepatic failure and liver cancer.
Several small, uncontrolled studies have suggested that treatment of
hepatitis C during the acute phase is highly effective, leading to sustained
clearance of virus in 80 to 98% of patients. What is unclear is the optimal
timing, dosage and treatment regimen for acute hepatitis. An application for
support of a collaborative network of investigators interested in studying
the natural history, immunopathogenesis, virology and treatment of acute
hepatitis C is strongly encouraged.
Studies on the prevention or treatment of overweight or obesity in children
and adults, including dietary, physical activity, pharmacologic, and surgical
approaches are of interest. The creative use of various devices,
technologies, or communication strategies to help individuals monitor energy
intake or energy expenditure in weight control programs would be appropriate.
Innovative studies that test the synergy of creative partnerships among
various groups such as industry, business, faith-based, academic, or
community organizations to enhance obesity prevention or treatment outcomes
are of interest. Studies of various approaches in combination to achieve
weight maintenance or to maintain weight loss, such as physical activity or
diet in combination with pharmacologic or surgical regimens would also be
appropriate.
Specific examples of research areas of interest include but are not limited
to:
o Disorders of GI function, including irritable bowel syndrome,
gastroparesis, nonulcer dyspepsia, colonic inertia, pseudoobstruction, ileus,
cyclic vomiting syndrome.
o Disorders characterized by GI inflammation, including inflammatory bowel
disease, celiac disease, collagenous colitis, microscopic colitis,
eosinophilic gastroenteritis.
o Disorders characterized by nutritional deficiency, including intestinal
failure and short gut syndrome.
o Preneoplastic conditions, such as Barrett’s esophagus.
o Gastrointestinal endoscopy research.
o Acute and chronic pancreatitis.
o Hepatobiliary diseases, including acute and chronic hepatitis B and C,
prevention and treatment of complications of liver transplantation,
autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing
cholangitis, Wilson’s disease, hepatic congenital fibrosis, biliary atresia
and neonatal cholestatic liver disease.
o Prevention and treatment of obesity, including: modification of dietary
practices or eating environments; strength training, aerobic conditioning, or
other modifications of physical activity and sedentary behavior; modification
of relevant associated behaviors that influence eating and physical activity
patterns or environmental conditions that may have an impact upon energy
balance.
o Altered nutrient requirements associated with physical activities or
disease states including how alterations in physical activities may change
nutritional requirements; effects of disease states on nutrient requirements.
o Interactions between nutrients, such as antioxidants and micronutrients on
mediators of the inflammatory responses.
o Role of alterations of dietary fatty acids on clinical mediators of
disease, for examples, prostaglandins.
o Genetic studies of digestive diseases or obesity seeking to assess the
sensitivity or specificity of a genetically based test, or to identify genes
influencing responses to a preventive or therapeutic intervention.
Summary
This program announcement is intended to encourage innovative clinical and
epidemiological research and to facilitate the translation of promising and
relevant new developments into the clinical setting. The emphasis is thus, on
the development of small, randomized clinical trials and epidemiological
studies. Basic laboratory research or studies of laboratory animals are not
appropriate for this R03 mechanism. Studies that do not involve human
subjects or are human studies that are not clinical trials or epidemiological
studies will not be supported through this program announcement and will be
returned to the proposed Principal Investigator without undergoing peer
review. Consideration should be given to using the R21
(https://grants.nih.gov/grants/guide/pa-files/PA-04-108.html) or R01
mechanism for this type of study.
The NIDDK is currently sponsoring several large, multi-center studies of
specific digestive diseases and nutritional disorders. These studies include
prospective studies in chronic hepatitis B and C; liver transplantation;
acute liver failure; hepatotoxicity; non-alcoholic steatohepatitis;
sclerosing cholangitis; biliary atresia; bleeding esophageal varices;
inflammatory bowel disease; and both behavioral and pharmacological therapy
of obesity; and outcomes research in bariatric surgery. Small grant
applications for clinical studies that specifically overlap with ongoing
studies sponsored by NIDDK may be denied funding.
MECHANISM OF SUPPORT
This PAR will use the NIH small grant (R03) award mechanism. Responsibility
for the planning, direction, and execution of the proposed project will be
solely that of the applicant. The total project period for an application
submitted in response to this PAR may not exceed two years. The budget may
be submitted for direct costs up to four modules of $25,000 each ($100,000
direct costs per year). These grants may not be renewed. Facilities and
Administrative (F & A) costs will be awarded based on the negotiated rate at
the time of each award.
Replacement of the Principal Investigator on this award is not permitted.
This PAR uses just-in-time concepts. It also uses the modular budgeting
format. (See https://grants.nih.gov/grants/funding/modular/modular.htm.)
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
ELIGIBLE INSTITUTIONS
You may submit an application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic institutions/organizations
o Faith-based or community-based organizations
o Foreign institutions are not eligible to apply
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
New and experienced investigators in relevant fields and disciplines may
apply for these small grants. New investigators are eligible, but they must
be independent of a mentor and have strong institutional support. NIDDK K08
and K23 recipients, who are eligible for R03 grants, may consider applying
for this R03 grant or for the R03 program for NIDDK K08/K23 recipients
(PAR-04-044).
Applicants from institutions that have a General Clinical Research Center
(GCRC) funded by the National Center for Research Resources may wish to
identify the GCRC as a resource for conducting the proposed research. If so,
a letter of agreement from either the GCRC program director or principal
investigator should be included with the application.
Applicants are encouraged to collaborate with the investigators in the Silvio
O. Conte Digestive Diseases Centers, Clinical Nutrition Research Centers, and
Obesity/Nutrition Research Centers for consultation in experimental design,
intervention, and methodology, as well as usage of core facilities
appropriate for carrying out their projects. Information describing the
centers and their cores can be requested from the person listed in INQUIRIES.
Applications from Veterans Administration (VA) Medical Centers and
collaborations with VA Medical Centers are encouraged. Several digestive and
nutritional conditions and diseases are particularly common among Veteran
patient populations and account for considerable morbidity and mortality in
Veterans. Conditions particularly common include chronic hepatitis C,
hepatocellular carcinoma, portal hypertension and cirrhosis. VA Medical
Centers often provide the ideal milieu for clinical investigation of
therapies that might benefit Veteran populations. The advanced medical
information systems developed by the Department of Veterans Affairs and the
ability to follow and maintain patient contact over many years make the VA
Medical Centers particularly well adapted to clinical and epidemiological
research in digestive diseases and nutritional disorders.
Interaction is encouraged between NIH-funded investigators and investigators
at CDC Prevention Research Centers, a national network of 28 academic
research centers that engage communities as participants in research on
preventing chronic diseases such as cancer, heart disease, and arthritis.
Information about CDC Prevention Research Centers may be found at:
http://www.cdc.gov/nccdphp/bb_prc/index.htm.
SPECIAL REQUIREMENTS
This NIDDK small grant support is for new projects only; competing
continuation applications will not be accepted. Small grant support may not
be requested for thesis or dissertation research. In addition, these R03
awards may not be used to supplement research projects currently supported by
Federal or non-Federal funds or to provide interim support of projects under
review by the Public Health Service.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PAR and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues.
o Direct your questions regarding scientific/research issues related to
digestive or hepatobiliary diseases or nutritional disorders to:
Patricia Robuck, Ph.D., M.P.H.
Director, Clinical Trial Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 659
Bethesda, MD 20817
Telephone: (301)594-8879
FAX: (301)480-8300
Email: pr132q@nih.gov
o Direct your questions regarding scientific/research issues related to
obesity to:
Robert Kuczmarski, Dr.P.H.
Director, Obesity Prevention and Treatment Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 673
Bethesda, MD 20892-5450
Telephone: (301)451-8354
FAX: (301)480-8300
E-mail: rk191r@nih.gov
o Direct inquiries regarding specific epidemiological programmatic issues to:
James Everhart, M.D., M.P.H.
Chief, Epidemiology and Clinical Trials Branch
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 655
Bethesda, MD 20817
Telephone: (301)594-8878
FAX: (301)480-8300
Email: je17g@nih.gov
o Direct your questions about peer review issues to:
Francisco Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 752
Bethesda, MD 20892-5452
Telephone: (301)594-8897
Fax: (301)480-3505
Email: fc15y@nih.gov
o Direct your questions about financial or grants management matters to:
Sharon T. Bourque
Grants Management Specialist
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Blvd., Room 719
Bethesda, MD 20892 MSC 5456
Telephone: (301)594-8846
FAX: (301)480-3504
Email: sb114m@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
The title and number of the PAR must be typed on line 2 of the face page of
the application form and the YES box must be checked.
SUPPLEMENTARY INSTRUCTIONS
Items a - d of the Research Plan [Specific Aims, Background and Significance,
Preliminary Studies (not required), and Research Design and Methods] may not
exceed a total of fifteen pages. Detailed descriptions of protocols for the
proposed involvement of human subjects and/or vertebrate animals, literature
cited, consortium/contractual arrangements and consultant letters are not
included in the fifteen-page limit.
Describe the particularly innovative/high impact aspects of the proposed
study in an introductory paragraph at the beginning of the research plan.
Include a description of how the outcome of this project would provide a
foundation for important new research in digestive diseases and nutritional
disorders. Label this paragraph, "Justification as Innovative/High Impact
Research."
For revised applications, an introduction (not to exceed one page) in
addition to the Research Plan is required. This introduction should respond
to the comments and concerns of the initial review group delineated in the
summary statement.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at https://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:
All applications submitted in response to this PAR must be submitted in a
modular budget grant format. The modular budget grant format simplifies the
preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Section C of the research grant application instructions for the PHS 398
(rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants. Additional
information on modular grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
https://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PAR that is essentially the
same as one currently pending initial review unless the applicant withdraws
the pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an unfunded version of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDDK. Incomplete applications will not be reviewed.
Applications that are complete and responsive to the PAR will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIDDK in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Diabetes and Digestive and
Kidney Diseases Advisory Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to evaluate each application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of the following criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive
this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
o The potential applicability of the research findings to the clinical
setting.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below.)
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below.)
ADDITIONAL REVIEW CONSIDERATIONS
o Because the research plan is limited to fifteen pages, these R03 small
grant applications may not have the same level of detail or extensive
discussion normally found in a regular R01 research project grant
application. Review emphasis will be placed on the conceptual framework and
general approach to the problem, with less emphasis on methodological
details.
o Since pilot/feasibility studies may not include preliminary data, the
review will focus on whether the rationale for the study is well developed
and whether the proposed research is likely to generate data that will lead
to additional studies that could potentially be funded as a regular research
project grant (R01).
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PAR will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PAR in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the “Standards for Privacy of Individually Identifiable Health Information”,
the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as “covered entities”) must do so by April 14, 2003 (with the
exception of small health plans, which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on “Am I a covered
entity?” Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
PAR is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
https://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.